Binimetinib - Generic Drug Details
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What are the generic drug sources for binimetinib and what is the scope of patent protection?
Binimetinib
is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Binimetinib has two hundred and twenty-six patent family members in fifty-five countries.
One supplier is listed for this compound.
Summary for binimetinib
| International Patents: | 226 |
| US Patents: | 10 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 92 |
| Patent Applications: | 3,165 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for binimetinib |
| What excipients (inactive ingredients) are in binimetinib? | binimetinib excipients list |
| DailyMed Link: | binimetinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for binimetinib
Generic Entry Date for binimetinib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for binimetinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cancer Research UK & UCL Cancer Trials Centre | Phase 3 |
| Accord Healthcare, Inc. | Phase 3 |
| Zymeworks Inc. | Phase 3 |
Paragraph IV (Patent) Challenges for BINIMETINIB
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MEKTOVI | Tablets | binimetinib | 15 mg | 210498 | 3 | 2022-06-27 |
US Patents and Regulatory Information for binimetinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for binimetinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for binimetinib
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pierre Fabre Medicament | Mektovi | binimetinib | EMEA/H/C/004579 Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
Authorised | no | no | no | 2018-09-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for binimetinib
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1119136 | ⤷ Try a Trial | |
| Mexico | 2012002546 | COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEINA. (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS.) | ⤷ Try a Trial |
| Slovenia | 2470526 | ⤷ Try a Trial | |
| South Korea | 100984573 | ⤷ Try a Trial | |
| Canada | 2478374 | UTILISATION DE DERIVES DE BENZIMIDAZOLE ALKYLES N3 EN TANT QU'INHIBITEURS DE MEK (N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS) | ⤷ Try a Trial |
| Portugal | 2470526 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for binimetinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2470526 | C201930019 | Spain | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1314; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1314; DATE OF FIRST AUTHORISATION IN EEA: 20180920 |
| 1482932 | 19C1014 | France | ⤷ Try a Trial | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1315 20180924 |
| 2470526 | CA 2019 00012 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1314 20180924 |
| 1482932 | C01482932/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019 |
| 2470526 | 300973 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
| 1482932 | 122019000022 | Germany | ⤷ Try a Trial | PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
